Oral communication, iL34

Official XXIst International Pigment Cell Conference website - 21-24 Sept 2011, Bordeaux - France | updated: September 04 2011

New developments in melanoma therapy - ASCO update

Two exciting developments in melanoma therapy were reported at ASCO 2011 as plenary lectures and simultaneously published as NEJM articles. Vemurafenib (PLX4032) was found to be highly active in the BRIM3 trial in patients with BRAF V600E mutation and achieved a hazard ratio of 0.37 for melanoma specific deaths in comparison to dacarbazine treatment, and the hazard ratio for tumor progressen was 0.26. Median follow-up at the reported interim analysis was only 3.8 months for patients in the vemurafenib group and 2.3 months for those in the dacarbazine group. In spite of this very short follow-up time the results were very impressing. Results from the BRIM2 trial with a median follow-up of 10 months in 132 patients treated with vemurafenib showed more elaborated survival data. While median overall survival time was not yet reached, the 12 months survival rate was 58% and the objective response rate was 53%. The median progression-free survival time was 6.7 months. A first report on the combination of the specific BRAF inhibitor GSK'436 with the MEK inhibitor GSK'212 showed ongoing responses in 83% of treated patients after a median follow-up of 5 months. Ipilimumab, a fully human, IgG1 monoclonal antibody, blocks cytotoxic T-lymphocyte–associated antigen 4 (CTLA-4), a negative regulator of T cells, and thereby augments T-cell activation and proliferation. A randomized trial in 502 patients with previously untreated metastatic melanoma was reported, comparing treatment with ipilimumab (10 mg per kilogram) plus dacarbazine to dacarbazine plus placebo. Overall survival was significantly longer in the group receiving ipilimumab plus dacarbazine than in the group receiving dacarbazine plus placebo (11.2 months vs. 9.1 months), with higher survival rates in the ipilimumab–dacarbazine group at 1 year (47.3% vs. 36.3%), 2 years (28.5% vs. 17.9%), and 3 years (20.8% vs. 12.2%). Toxicity was moderate and manageable. These new treatment modalities are presently available in early access programs.

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